Krege S, Giani G, Meyer R, Otto T, Rübben H
Department of Urology, University of Essen Medical School, Germany.
J Urol. 1996 Sep;156(3):962-6. doi: 10.1016/s0022-5347(01)65673-8.
A randomized multicenter trial was done to compare transurethral resection only to transurethral resection plus adjuvant mitomycin C and bacillus Calmette Guerin (BCG) instillation for treatment of superficial bladder cancer (stage pTa/1 grades 1 to 3 except primary stage pTa grade 1).
Included in the study were 337 patients with superficial stage pTa/1 grades 1 to 3 bladder cancer except primary stage pTa grade 1 tumors. One group underwent transurethral resection alone. Mitomycin C (20 mg./50 ml. sodium chloride) was given every 2 weeks during year 1 and once a month during year 2. BCG (120 mg/50 ml. sodium chloride was instilled once a week for 6 weeks and once a month for 4 months.
At a median followup of 20.2 months, a decrease in recurrence rate was noted for both drug instillations compared to transurethral resection only. The relative risk of recurrence was 0.508 after mitomycin C and 0.618 after BCG instillation compared to transurethral resection alone. There was no significant difference between the mitomycin C and BCG instillations. The progression rate was comparable in all 3 therapy groups, with an estimated common progression rate of 4.22% per year. Side effects occurred most frequently during or after BCG instillation, most often consisting of cystitis. One patient required cystectomy because of ulcerating cystitis and a prostatic abscess subsequent to unsuccessful tuberculostatic therapy. There were no systemic complications.
Our study showed a positive effect of adjuvant chemotherapy and immunotherapy on decreasing tumor recurrence rate. No influence was observed concerning progression rate, which was low overall.
开展一项随机多中心试验，比较单纯经尿道切除术与经尿道切除术联合辅助丝裂霉素C及卡介苗（BCG）膀胱灌注治疗浅表性膀胱癌（pTa/1期，1至3级，但原发pTa 1级除外）的疗效。
本研究纳入了337例浅表性pTa/1期，1至3级膀胱癌患者，但原发pTa 1级肿瘤患者除外。一组仅接受经尿道切除术。丝裂霉素C（20 mg/50 ml氯化钠）在第1年每2周给药1次，第2年每月给药1次。卡介苗（120 mg/50 ml氯化钠）每周灌注1次，共6周，之后每月灌注1次，共4个月。
中位随访20.2个月时，与单纯经尿道切除术相比，两种药物灌注均使复发率降低。与单纯经尿道切除术相比，丝裂霉素C灌注后复发的相对风险为0.508，卡介苗灌注后为0.618。丝裂霉素C和卡介苗灌注之间无显著差异。所有3个治疗组的进展率相当，估计年共同进展率为4.22%。副作用最常发生在卡介苗灌注期间或之后，最常见的是膀胱炎。1例患者因膀胱炎溃疡及抗结核治疗失败后继发前列腺脓肿而需要行膀胱切除术。无全身并发症。
我们的研究表明辅助化疗和免疫治疗对降低肿瘤复发率有积极作用。未观察到对进展率的影响，总体进展率较低。
